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ENSURING RISK-BASED MONITORING SUCCESS – KEEP IT SIMPLE!

Roberta Alexander, Ph.D.: May 28, 2015 5:22:00 PM

San Diego Clinical Research Network (SDCRN) organized another great event on May 21, 2015 to address Risk Based Monitoring (RBM) in clinical trials. This event was co-organized with OmniComm, an Electronic Data Capture and eClinical Solutions company, and ResearchPoint Global, a full-service CRO with 22 global offices and clinical coverage in more than 60 countries.

Clinical Operations Quality – What Is It and How Is It Ensured?

Steve Young: May 16, 2015 1:12:00 PM

What do we mean when we talk about “quality” in the context of conducting clinical research?  Quality can be a very elusive concept.  Fortunately we have a documented set of rules and guidelines – under the umbrella of Good Clinical Practice (GCP) – that establish objective standards by which quality in clinical research is judged.  The volume of GCP regulations and related guidance is extensive, but virtually all of it is directed at the following two imperatives: